Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- re-operation rate
研究概览
简要总结
The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).
详细描述
This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).
All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.
Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.
Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.
After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AO/OTA 31-A2 fractures
- •age between 18 - 100 years
- •Signed written informed consent and agreement to attend the planned FUs
- •Able to understand and read country national language at an elementary level
排除标准
- •missing informed consent form
- •pathological fracture
- •incomplete patient record
- •death within one month of intervention (surgery)
- •prior surgery to the hip
- •polytrauma
- •any additional fracture
- •any implant at the same hip
- •infection
研究组 & 干预措施
Gamma Nail 3
Gamma Nail 3 Stryker.
干预措施: Gamma Nail 3 (Device)
PFNA
PFNA Antirotation Synthes
干预措施: PFNA (Device)
结局指标
主要结局
re-operation rate
时间窗: time between intervention and one year after
次要结局
- Screw-Cut Out(time between intervention and one year after)
研究者
Harry Widhalm
M.D.
Medical University of Vienna
